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FDA Clears Paradromics' Long-Term Brain Implant Trial to Restore Speech

Regulators cleared Paradromics to evaluate a high-bandwidth implant for restoring communication through decoded speech.

Overview

  • The early-stage study is scheduled to begin next year with two volunteers who have lost the ability to speak because of neurological disease.
  • Paradromics’ Connexus uses a penetrating microwire array in the motor cortex linked by a subcutaneous lead to a powered wireless transceiver implanted in the chest.
  • The trial targets decoding attempted speech into on-screen text or real-time synthetic voice, with plans to clone a participant’s voice when recordings exist, marking the first BCI trial to formally pursue synthetic-voice generation.
  • Researchers will also test imagined hand movements for computer cursor control, with a potential expansion to as many as ten participants and bilateral implants pending early safety and performance data.
  • Paradromics cites preclinical results showing 200 bits per second in sheep and reports a prior 10-minute intraoperative human test, with the new study shifting to long-term implantation to assess safety and communication efficacy.